Contact Us

Latest News

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2025-8 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles

by

The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to improve the identification and traceability of medical devices. Manufacturers must assign UDI codes (Basic UDI-DI, UDI-DI, and UDI-PI) to most devices before placing them on the market and register key identifiers in the EUDAMED database. For highly individualised devices, such as … Read more

closeup of flag of Union Jack, uk england, united kingdom flag

MHRA Launches a Consultation on Indefinite Recognition of CE-marked Medical Devices 

by

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to introduce indefinite recognition of CE-marked medical devices in Great Britain (GB). The initiative is intended to safeguard patient access and ensure the continued supply of safe and effective medical technologies. Approximately 90% of medical devices currently used in GB … Read more

IVDR

TEAM NB Publish Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment

by

Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB … Read more

Concept of MDR Medical Device Regulation.

Team NB Publish Position Paper on MDR/IVDR Revision

by

Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the … Read more

Advena.mt main logo

Advena at WHX Dubai 2026

by

Earlier this month, we had the pleasure of exhibiting our services at WHX Dubai (formerly Arab Health). The event provided an excellent platform to connect with a wide range of medical device manufacturers from around the world who are seeking CE Marking for their products and access to the European Union market. The exhibition also … Read more

Concept of MDR Medical Device Regulation.

COMMISSION IMPLEMENTING DECISION (EU) 2026/193

by

Commission Implementing Decision (EU) 2026/193 has been published, introducing a total of 12 new harmonised standards. These standards span a broad range of areas, including neurosurgical implants, sterilisation of healthcare products, and the biological evaluation of breathing gas pathways used in healthcare applications. The full list of harmonised standards can be seen listed below; Compliance … Read more

EC survey for MD/IVD manufacturers and ARs on the status of the MDR/IVDR implementation – invitation to participate

by

The Austrian National Public Health Institute is conducting a survey on behalf of the European Commission (DG SANTE/HaDEA) to collect information and data on the status of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/745 (IVDR). The aim of this survey is to get a realistic picture of the status of the … Read more

Concept of MDR Medical Device Regulation.

New Notified Body has been Designated Under the MDR

by

The first Notified Body under the Medical Device Regulation (MDR) has officially opened in Malta, marking an important milestone for both the local life sciences sector and the wider European medical device landscape. In simple terms, a Notified Body (NB) designated under the Medical Device Regulation (EU) 2017/745 is an independent, third-party organisation appointed by … Read more

Concept of MDR Medical Device Regulation.

ISO 10993-1:2025 – Biological evaluation of medical devices. Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

by

ISO 10993-1:2025 has recently been published, introducing important updates to the cornerstone standard for the biological evaluation of medical devices. ISO 10993-1 plays a critical role in defining the principles and requirements for assessing the biological safety of medical devices within the broader risk management framework established by ISO 14971. The standard guides manufacturers and … Read more

+ More
13485_SGQ-MED_sg04

Advena Ltd

Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 76865

Advena Services Ltd

Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 103067

Advena Malta (Holdings) Ltd

Registered Address:
Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474

Advena SRL

Registered Address:
Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259

Reach out for a consultation.

EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices

Contact Us

Quick Links

Contact

+356 2546 6689

info@advenaltd.eu

Contact Us

Connect

© 2026 Advena Ltd

Privacy Policy Terms of Service

Proudly designed by </encode>

Advena.mt Logo Website
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.